NDC 54838-514

Clemastine Fumarate

Clemastine Fumarate

Clemastine Fumarate is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Clemastine Fumarate.

Product ID54838-514_00a84afa-9348-4cd4-8151-2afab977ea09
NDC54838-514
Product TypeHuman Prescription Drug
Proprietary NameClemastine Fumarate
Generic NameClemastine Fumarate
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date1997-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA074884
Labeler NameLannett Company, Inc.
Substance NameCLEMASTINE FUMARATE
Active Ingredient Strength1 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54838-514-40

120 mL in 1 BOTTLE, PLASTIC (54838-514-40)
Marketing Start Date1997-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54838-514-40 [54838051440]

Clemastine Fumarate SYRUP
Marketing CategoryANDA
Application NumberANDA074884
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-12-17

NDC 54838-514-80 [54838051480]

Clemastine Fumarate SYRUP
Marketing CategoryANDA
Application NumberANDA074884
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-12-17

Drug Details

Active Ingredients

IngredientStrength
CLEMASTINE FUMARATE.67 mg/5mL

OpenFDA Data

SPL SET ID:3f5dbf44-7cad-491f-ad5f-ad4bd06682a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857430
  • UPC Code
  • 0354838514407
  • NDC Crossover Matching brand name "Clemastine Fumarate" or generic name "Clemastine Fumarate"

    NDCBrand NameGeneric Name
    0093-0308Clemastine FumarateClemastine Fumarate
    51655-425Clemastine FumarateClemastine Fumarate
    54838-514Clemastine FumarateClemastine Fumarate
    68151-2456Clemastine FumarateClemastine Fumarate
    73308-358Clemastine FumarateClemastine Fumarate
    42507-282Dayhist allergyClemastine fumarate
    24385-183Good Neighbor Pharmacy Dayhist AllergyClemastine fumarate
    70000-0216Leader AllerhistClemastine fumarate
    49348-686SUNMARK 12 HOUR ALLERGY RELIEFClemastine fumarate
    0363-0707wal histClemastine fumarate

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